felodipine Side Effects
Also known as: Plendil
Analysis of 11,019 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
11,019
Death-Related
840
7.6% of reports
Hospitalizations
4,925
44.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 840 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 162 |
| PNEUMONIA | 74 |
| DYSPNOEA | 63 |
| ANAEMIA | 52 |
| CARDIAC ARREST | 50 |
| RENAL FAILURE | 49 |
| LOSS OF CONSCIOUSNESS | 45 |
| MYOCARDIAL INFARCTION | 45 |
| PYREXIA | 45 |
| HYPOTENSION | 43 |
| RESPIRATORY FAILURE | 41 |
| FATIGUE | 37 |
| OFF LABEL USE | 37 |
| VOMITING | 36 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 35 |
| FALL | 34 |
| OVERDOSE | 34 |
| SEPSIS | 34 |
| RENAL FAILURE ACUTE | 33 |
| ASTHENIA | 32 |
Reactions in Hospitalization Reports
Top reactions in 4,925 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 463 |
| DIZZINESS | 444 |
| NAUSEA | 356 |
| FATIGUE | 335 |
| DIARRHOEA | 327 |
| VOMITING | 298 |
| PYREXIA | 297 |
| CHEST PAIN | 258 |
| HEADACHE | 247 |
| MALAISE | 247 |
| CONFUSIONAL STATE | 246 |
| PAIN | 237 |
| DEHYDRATION | 234 |
| MYOCARDIAL INFARCTION | 225 |
| FALL | 219 |
| HYPOTENSION | 213 |
| PNEUMONIA | 210 |
| ASTHENIA | 206 |
| HYPONATRAEMIA | 206 |
| OFF LABEL USE | 198 |
Nearby — Related Medications
What the FAERS Data Reveals About felodipine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 11,019 voluntary reports linked to felodipine and its brand equivalents (Plendil), spanning 2001 through 2025. Of those, 840 (7.6%) listed death as an outcome and 4,925 (44.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 49% were female and 51% male; age distribution skews toward 75+, with 3,035 reports in that bracket. The single most reported reaction is fatigue with 1,051 submissions, followed by dyspnoea and dizziness.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.